Digital intelligence blog

FDA teams up with PatientsLikeMe for patient data project

Will explore its potential to inform the regulator'approach to risk assessment

The FDA
is set to investigate whether patient-reported data can give it new insights
into the safety of the products it approves.

The US
regulator has teamed up with online patient community PatientsLikeMe to explore
how the data that patients generate could “inform regulatory review activities
related to risk assessment and risk management”.

PatientsLikeMe
co-founder and president Ben Heywood said the agreement was an “unprecedented
step toward enhancing post-market surveillance and informing regulatory
science”.

He
added: “Most clinical trials only represent the experience of several hundred
or at most several thousand patients, making it impossible to anticipate all
the potential side effects of drugs in the real world.

“Patient-generated
data give a more complete picture about a drug's safety by providing a window
into patients' lives and healthcare experiences over time. We're very
encouraged by the FDA's action to evaluate newer sources of data to help
identify benefits and risks earlier.”

At
present the majority of post-approval drug safety reports reach the FDA from
drug manufacturers, and are either recorded directly by the company or
submitted by healthcare professionals (HCPs) and patients.

Firms have
to report any reports they receive, but HCPs and patients - who can also send
reports directly to the regulatory via the FDA Adverse Event Reporting
System (FAERS) - are not obliged to contact the FDA about their drug safety
concerns.

PatientsLikeMe
said its data is of different kind to that the FDA receives from FAERS, being generated
in a different context by patients themselves. The company
hopes it will provide real-time insights into the nuances inherent in patients'
experiences of particular medicines, including information on drug tolerance, adherence
and quality of life.

Formed in 2004 with an
initial focus on the neurodegenerative disease ALS (amyotrophic
lateral sclerosis), PatientsLikeMe now covers over 2,500 different conditions
and has more than 350,000 members.

Its
latest research collaboration is the first time PatientsLikeMe has formally
worked with the FDA, but its drug safety work has been going since 2008, when
it launched a pilot programme that allowed multiple sclerosis patients to
report adverse events directly to the regulator. One year later the company launched
a social media drug safety platform.

To date
PatientsLikeMe has collected more than 110,000 adverse event reports on 1,000
different medications - data, the company said, that will now be available to the
FDA to supplement its more traditional sources such as FAERS.